Application 065070

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE	DOXYCYCLINE	TABLET;ORAL	EQ 50MG BASE	No	No
002	DOXYCYCLINE	DOXYCYCLINE	TABLET;ORAL	EQ 100MG BASE	No	No
003	DOXYCYCLINE	DOXYCYCLINE	TABLET;ORAL	EQ 75MG BASE	No	No
004	DOXYCYCLINE	DOXYCYCLINE	TABLET;ORAL	EQ 150MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A065070-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2000-12-15
A065070-002	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2000-12-15
A065070-003	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2002-12-30
A065070-004	DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2005-07-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A065070-001	AB
A065070-002	AB
A065070-003	AB
A065070-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065070-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2000-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065070-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2000-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065070-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2002-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065070-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2005-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065070-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2000-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065070-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2000-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065070-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2002-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065070-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2005-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065070-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2000-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065070-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2000-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065070-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2002-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065070-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2005-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065070-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2000-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065070-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2000-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065070-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2002-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065070-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2005-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065070-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2000-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065070-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2000-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065070-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2002-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065070-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2005-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065070-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2000-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065070-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2000-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065070-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2002-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065070-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2005-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065070-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2000-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065070-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2000-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065070-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2002-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065070-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2005-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065070-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2000-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065070-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2000-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065070-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2002-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065070-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2005-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065070-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2000-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065070-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2000-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065070-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2002-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065070-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2005-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065070-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2000-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065070-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2000-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065070-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2002-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065070-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2005-07-14	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065070-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065070-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065070-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065070-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065070-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065070-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065070-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065070-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065070-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065070-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065070-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065070-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065070-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065070-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065070-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065070-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065070-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065070-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065070-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065070-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065070-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065070-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065070-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065070-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065070-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065070-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065070-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065070-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065070-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065070-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065070-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065070-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065070-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065070-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065070-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065070-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065070-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065070-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065070-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065070-004	AB	1	`d06236e962d9…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	Strides Pharma Science Limited	3b9888a2-ca16-43f7-ab6d-f03188ec2c0d	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065070 application number: ANDA065070 ndc (product): 64380-206 ndc (product): 64380-207 ndc (product): 64380-208 ndc (product): 64380-205

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-091	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-091	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-092	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-092	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-093	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-093	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-236	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-236	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
64380-205	Doxycycline	doxycycline	Strides Pharma Science Limited	ANDA	Current
64380-206	Doxycycline	doxycycline	Strides Pharma Science Limited	ANDA	Current
64380-207	Doxycycline	doxycycline	Strides Pharma Science Limited	ANDA	Current
64380-208	Doxycycline	doxycycline	Strides Pharma Science Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30648	ORIG	2000-12-15